• 27 February 2013

    Santhera Pharmaceuticals (SIX: SANN) announced today the voluntary withdrawal of Catena® from the Canadian market. This decision follows review of additional data from clinical trials in patients with Friedreich's Ataxia, and subsequent consultation with Health Canada.

  • 1 February 2013

    Endosense, a pioneer and leader in contact-force sensing technology focused on improving the efficacy and safety of catheter ablation for the treatment of cardiac arrhythmias, has announced that its new generation TactiCath Quartz contact-force sensing ablation catheter has been used for the first time in the United States by Dr. J. Michael Mangrum at University of Virginia Medical Center in Charlottesville, Va. The first U.S. case was performed on January 31 as part of an amended protocol of the company’s TOCCASTAR investigational device exemption (IDE) clinical study of the TactiCath (called the "TOCCASTAR Supplemental Clinical Study"). The supplemental study’s protocol is identical to that of original TOCCASTAR study, with the exception that the patients treated with the newer device will not be randomized. 

  • 18 January 2013

    Santhera Pharmaceuticals (SIX: SANN) announced today that it has received a negative opinion on its Marketing Authorization Application (MAA) for Raxone® as a potential therapy for Leber’s Hereditary Optic Neuropathy (LHON). The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has notified Santhera that a narrow majority of CHMP members deemed Raxone® not approvable at this time. Santhera believes that the clinical benefit of Raxone® in patients in whom the medical need for treatment was most urgent had not been fully considered and therefore has decided to request a re-examination of the opinion.

  • 7 January 2013

    JenaValve Technology, Inc., a privately-held, venture-backed developer, manufacturer and marketer of transcatheter-delivered aortic valve systems (TAVI) for the treatment of aortic valve disease, announced today that it has appointed veteran medical device executive Raymond W. Cohen as Executive Chairman of its Board of Directors.

  • 27 November 2012

    Endosense, a pioneer and leader in force-sensing technology focused on improving the efficacy and safety of catheter ablation for the treatment of cardiac arrhythmias, has announced the close of a USD 40.3 million/CHF 37.4 million series C financing. Led by new investor NGN Capital, the round drew large participation from all existing investors, including Edmond de Rothschild Investment Partners, NeoMed Management, Gimv, VI Partners, Sectoral Asset Management, Ysios Capital Partners and Initiative Capital Romandie, as well as multiple employees. Proceeds will be used to support the growth of a new direct sales organization in Europe; commercialization of the recently introduced third-generation TactiCath Quartz forcesensing catheter in the region; development of next generation products; completion of the TOCCASTAR investigational device exemption (IDE) clinical study follow-up and FDA approval submission for the TactiCath; and, the launch of the device in the United States.